News: The Company reported positive interim results from its phase II study of RA101495 SC in Paroxysmal Nocturnal Hemoglobinuria, or PNH. However, investors seem to be not impressed with the results.

The study consists of three cohorts. Cohort A includes PNH patients who were never treated with Soliris, Cohort B included patients switching from Soliris to RA101495, and Cohort C includes patients who are currently treated with Soliris, but with not much of a response.

Soliris, developed by Alexion Pharmaceuticals Inc. (ALXN) is an approved therapy for PNH.

Paroxysmal nocturnal hemoglobinuria, or PNH, is a condition in which red blood cells break apart prematurely, causing fatigue, shortness of breath and weakness. Blood transfusion is one way of easing the symptoms of this rare disorder. High levels of lactate dehydrogenase in the blood can mean that red blood cells are breaking apart (hemolysis) (Source: AAMDS.org).

In the first cohort of the study, there was rapid, robust, and sustained reduction in lactate dehydrogenase (LDH) levels from baseline to the mean of Weeks 6-12 in patients treated with RA101495 SC. About 50% of patients who were transfusion-dependent prior to enrollment have been transfusion-free since commencing treatment with RA101495 SC.

In the second cohort, when transfusion-independent patients on long-term Soliris therapy, switched to RA101495 SC, they had stable LDH levels and had no episodes of breakthrough hemolysis. However, in the same cohort of patients who were difficult to treat with Soliris and who were transfusion-dependent at baseline switched to RA101495 SC, breakthrough hemolysis occurred in 7 patients, and all 7 had to be reverted to Soliris without complications.

The third cohort has enrolled only three patients, and LDH stabilization and relief of side effects associated with Soliris intolerance have been observed in the first patient enrolled in this cohort.

--Results of the independent central blinded review along with sensitivity analyses of prior treatment regimens of the phase II study of IMMU-132 in patients with metastatic triple-negative breast cancer are scheduled for presentation on December 7, 2017.-- Submit BLA for IMMU-132 for metastatic triple-negative breast cancer in the first quarter of 2018.

Lost 11.65% to close Monday's trading at $2.35. The stock has lost 30% in the last 5 trading days.

News: No news

Pipeline:

The Company's lead product candidate is Presbia Flexivue Microlens, a revolutionary optical lens implant for treating presbyopia, the age-related loss of near vision. The Presbia Flexivue Microlens is currently approved for sale in 42 countries around the world.

Near-term catalyst:

-- The Company is planning to make its final submission to the FDA seeking approval of Presbia Flexivue Microlens before the end of 2017, with approval expected in 2018.

-- On October 3, 2017, the Company closed its initial public offering of 7.5 million shares of its common stock at a public offering price of $17.00 each.

Pipeline:

The Company's lead candidate is DCC-2618, currently in a first-in-human Phase 1 clinical trial. DCC-2618 is in clinical development for the treatment of KIT and/or PDGFRa-driven cancers, including gastrointestinal stromal tumors, glioblastoma multiforme and systemic mastocytosis.

Near-term catalysts:

-- Plans to initiate two pivotal phase III clinical trials of DCC-2618 in gastrointestinal stromal tumors in 2018 - a placebo-controlled randomized, pivotal Phase 3 clinical trial in patients with fourth-line GIST in the first half of 2018 and a second pivotal Phase 3 clinical trial comparing DCC-2618 to sunitinib in second-line GIST patients in the second half of 2018.